Alges (Hefilcon A) Contact Lens

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Alges(Tm) (Hefilcon a) Contact Lens

Generic Name

Lenses, soft contact, daily wear

PMA Number

P850002 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001

• Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact Lens

  Class II

  FDA 510(k) K082393 Active Cleared 11 Sep 2008

• Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens

  Class II

  FDA 510(k) K960926 Active Cleared 10 Apr 1996

• Simulvue 38 (Polymacon) Soft (Hydrophilic) Bifocal Contact Lens

  Class II

  FDA 510(k) K942372 Active Cleared 7 Jul 1994

• Unilens 38 Soft Aspheric Contact Lens

  Class II

  FDA 510(k) K941836 Active Cleared 7 Jul 1994

• Seesoft (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens

  Class II

  FDA 510(k) K960380 Active Cleared 28 Mar 1996

• Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, Ll-38, Bayvue Aquaflex Mto, Unilens 38, Unisoft, Simulvue 38 Llbi 2,

  Class II

  FDA 510(k) K110452 Active Cleared 20 Apr 2011

See all devices from Unilens Corp., USA →

• What is the primary material used in the Alges™ (Hefilcon A) Contact Lens, and how does it benefit the wearer?

  The Alges™ (Hefilcon A) Contact Lens is constructed from Hefilcon A, a silicone hydrogel material. This material is designed to provide extended wear comfort while maintaining optical clarity, making it suitable for daily use. Silicone hydrogels are known for their ability to allow higher oxygen transmission compared to traditional hydrogel materials, which can help reduce dryness and improve overall wearer comfort.

• Is the Alges™ (Hefilcon A) Contact Lens intended for single-use or reusable applications, and how should it be handled?

  The Alges™ (Hefilcon A) Contact Lens is intended for single-use or daily disposable applications, meaning it is non-reusable and supplied sterile. Proper fitting and handling are required to ensure patient safety and efficacy, as outlined in the FDA Premarket Approval (PMA) guidelines. This design minimizes the risk of infection and maintains hygiene standards.

• What regulatory pathway does the Alges™ (Hefilcon A) Contact Lens follow, and what does this mean for its approval status?

  The Alges™ (Hefilcon A) Contact Lens follows the FDA Premarket Approval (PMA) pathway, specifically under regulation number 886.5925 and PMA number P850002. This means the device underwent rigorous review by the FDA to ensure safety, effectiveness, and compliance with regulatory standards before approval. The approval status is tied to this specific PMA process.

• Are there multiple sizes and powers available for the Alges™ (Hefilcon A) Contact Lens, and how does this affect fitting?

  Yes, the Alges™ (Hefilcon A) Contact Lens is available in various sizes and powers, as indicated by the multiple FEI numbers listed in the regulatory data. This range allows for customized fitting to accommodate different prescription needs and corneal shapes. Proper selection of size and power by an eye care professional is essential to ensure optimal vision correction and comfort.

• How should the Alges™ (Hefilcon A) Contact Lens be stored, and what precautions should be taken?

  While the data does not specify storage instructions explicitly, as a sterile, single-use contact lens, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is non-reusable, unopened lenses should be kept in their original packaging until use. Always follow manufacturer guidelines or eye care professional recommendations to maintain sterility and integrity before application.